Quality Assurance Associate

Description Overview

This position is responsible for the quality assurance supervision of third-party manufacturers, packers, and storage facilities. 
This includes performing Perrigo product release, auditing, addressing customer complaints and deviations associated with third party manufacturers.

A key aspect of this role is establishing relationships with third party suppliers to enhance product quality and Perrigo Australia manufacturing effectiveness and efficiency.

Work with a high level of independence. 
Maintain an effective working relationship with all staff and third-party contractor personnel.

The contracted hours for this role will be 20 hours per week. 

The ideal candidate will be based in Western Australia and work remotely. 
 

Scope of the Role

• Identify and assess new Contractors in conjunction with relevant department.
• Prepare and maintain GMP / Quality agreements with all Contractors to ensure all responsibilities are clearly stated, all GMP requirements are specified, and that Perrigo’s interests are protected from a quality, GMP and commercial perspective where required.
• Monitor Contract manufactures quality indicators and performance to identify potential problems before they affect product.
• Greater than 95% compliance with the training requirements. Attend all training sessions as determined by Manager.
• Encourage a Quality culture with all staff and always act in a manner in accordance with quality standards and Perrigo’s values.
• Ensure relevant standards are complied with and that changes to the Perrigo Quality Management System within the scope of the department are in line with internal and external requirements.

Batch Release

• Perform Release for Distribution for Products manufactured by Contractors and other Perrigo sites where specified in GMP / Quality agreements in accordance with the products Marketing Authorisation and company procedures.

Training

• Performing cGMP / ISO training for Perrigo personnel and Contractors.
• Perform on the job training on specific job function, process or procedure as required.
   

Quality Systems

• Review deviations from third party manufacturers to ensure the investigation has adequately determined; the scope, assessed the impact on the product and the root cause. Based on the deviation’s investigation ensure agreement with the contract manufactures product disposition decision. Where the deviation investigation is not adequate, or the disposition decision is not appropriate work with Contractors Quality representative to reach a suitable outcome to the situation.
• Review Corrective actions proposed by the Contractor to ensure they are adequate. Track all corrective and preventative actions approved to ensure timely closure.
• Investigate customer complaints, determine suitable response and associated corrective and preventative action as required.
• Assess Contractor Change controls to assess, appropriateness of the change, impact on marketing authorisation, adequacy of risk assessments and implantations plan of the change control.

Review the following quality documents for adequacy and completeness:

• Master Batch Records
• Product Specifications
• Product Test Procedures
• Validation Protocols and Reports
• Stability Protocols and Reports
• Periodic Product Quality Reviews
• Change Controls

• Perform internal and external audits as specified by QA Manager to assess compliance to relevant industry standards, company policies and procedures and contractual obligations.

Experience Required

• Tertiary qualifications in science or engineering.
• 5-7 years’ experience in the pharmaceutical or similar manufacturing industry.
• Experience in the development, operation and maintenance of relevant quality assurance management systems.
• Understanding of chemical and microbiological test process used in the pharmaceutical industry.
• Understanding of Marketing Authorization process in Australia and New Zealand.
• The ability to create meaningful relationships with a broad range of people.
• Proficient in Microsoft Outlook, Excel, Word, Power point and ability to learn new software applications.